NDC 63187-383

Dexamethasone

Dexamethasone

Dexamethasone is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Proficient Rx Lp. The primary component is Dexamethasone.

Product ID63187-383_2c918fc8-1110-4bc5-b0a8-230a2b91e67e
NDC63187-383
Product TypeHuman Prescription Drug
Proprietary NameDexamethasone
Generic NameDexamethasone
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date1982-08-26
Marketing CategoryANDA / ANDA
Application NumberANDA087916
Labeler NameProficient Rx LP
Substance NameDEXAMETHASONE
Active Ingredient Strength2 mg/1
Pharm ClassesCorticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]
NDC Exclude FlagN
Listing Certified Through2022-12-31

Packaging

NDC 63187-383-05

5 TABLET in 1 BOTTLE, PLASTIC (63187-383-05)
Marketing Start Date2016-09-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 63187-383-24 [63187038324]

Dexamethasone TABLET
Marketing CategoryANDA
Application NumberANDA087916
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2016-09-01

NDC 63187-383-90 [63187038390]

Dexamethasone TABLET
Marketing CategoryANDA
Application NumberANDA087916
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2016-09-01

NDC 63187-383-60 [63187038360]

Dexamethasone TABLET
Marketing CategoryANDA
Application NumberANDA087916
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2016-09-01

NDC 63187-383-30 [63187038330]

Dexamethasone TABLET
Marketing CategoryANDA
Application NumberANDA087916
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2016-09-01

NDC 63187-383-05 [63187038305]

Dexamethasone TABLET
Marketing CategoryANDA
Application NumberANDA087916
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2016-09-01

Drug Details

Active Ingredients

IngredientStrength
DEXAMETHASONE2 mg/1

OpenFDA Data

SPL SET ID:35307d74-aed8-4c6b-9568-2223a4f350bd
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 197581

    • Pharmacological Class

    • Corticosteroid [EPC]
    • Corticosteroid Hormone Receptor Agonists [MoA]
    • Corticosteroid [EPC]
    • Corticosteroid Hormone Receptor Agonists [MoA]

    NDC Crossover Matching brand name "Dexamethasone" or generic name "Dexamethasone"

    NDCBrand NameGeneric Name
    0054-3177DexamethasoneDexamethasone
    0054-4179DexamethasoneDexamethasone
    0054-4180DexamethasoneDexamethasone
    0054-4181DexamethasoneDexamethasone
    0054-4182DexamethasoneDexamethasone
    0054-4183DexamethasoneDexamethasone
    0054-4184DexamethasoneDexamethasone
    0054-4186DexamethasoneDexamethasone
    0054-8174DexamethasoneDexamethasone
    68071-4127DexamethasoneDexamethasone
    68788-7142DexamethasoneDexamethasone
    68788-7267DexamethasoneDexamethasone
    68788-9939DexamethasoneDexamethasone
    68788-9938DexamethasoneDexamethasone
    0054-8176DexamethasoneDexamethasone
    0054-8181DexamethasoneDexamethasone
    0054-8183DexamethasoneDexamethasone
    0054-8180DexamethasoneDexamethasone
    0054-8175DexamethasoneDexamethasone
    0054-8179DexamethasoneDexamethasone
    70518-0843DexamethasoneDexamethasone
    70518-1534DexamethasoneDexamethasone
    71335-0177DexamethasoneDexamethasone
    71335-0077DexamethasoneDexamethasone
    10544-211DexamethasoneDexamethasone
    10544-212DexamethasoneDexamethasone
    0095-0089DexamethasoneDexamethasone
    0095-0088DexamethasoneDexamethasone
    0095-0087DexamethasoneDexamethasone
    21695-382DexamethasoneDexamethasone
    21695-290DexamethasoneDexamethasone
    21695-728DexamethasoneDexamethasone
    21695-745DexamethasoneDexamethasone
    33261-625DexamethasoneDexamethasone
    42195-151DexamethasoneDexamethasone
    43063-266DexamethasoneDexamethasone
    48102-048DexamethasoneDexamethasone
    48102-047DexamethasoneDexamethasone
    48102-046DexamethasoneDexamethasone
    48102-045DexamethasoneDexamethasone
    49999-059DexamethasoneDexamethasone
    49884-085DexamethasoneDexamethasone
    49884-086DexamethasoneDexamethasone
    49884-087DexamethasoneDexamethasone
    49884-373DexamethasoneDexamethasone
    49884-084DexamethasoneDexamethasone
    50090-0091DexamethasoneDexamethasone
    50090-0090DexamethasoneDexamethasone
    50090-0088DexamethasoneDexamethasone
    50090-0089DexamethasoneDexamethasone
    © 2026 FDA.report
    This site is not affiliated with or endorsed by the FDA.